Job Description

We are recruiting for a Senior Regulatory Affairs Associate in Spain we are flexible with homebased or office-based candidates. You will beaccountable for leading operational submissions execution for designated CTAs. You will operate as regulatory operational Subject Matter Expert for a CTA and drive submission teams.

Role Responsibilities:

Drives global submission management strategy and activities for assigned protocols. Partners with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development including authoring of Annex I and completion of relative associated documentation as required

Lead and attends relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities

Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.

Liaises with Core team, SSU and Study Management, regarding essential core documents and local documentation as need from relevant supplier lines across both HA and EC submission and translation processes

Prepare, review and submit submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.

Responsible for the co-ordination of translations for core documents required for submission

Manages the compilation for core package build, contributing to CTA and authoring documentation as required

Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.

Discussed with relevant SMEs the interpretation of dossier requirement

Qualifications

Desirable Skills:
• Project management knowledge
• Client-focused approach to work
• Results orientation
• Teamwork and collaboration skills
• Excellent interpersonal and intercultural communication skills, both written and verbal
• Critical thinking and problem-solving skills
• Proficiency in local language and extensive working knowledge of the English language

Knowledge and Experience:
• Several years of experience working for a CRO

Education:
• Minimum of a Bachelor's Degree in a Scientific or Technical DisciplineWhy Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.